Clinical trial · Interventional
PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port
Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port
NCT00600444CI-TRIAL-00003067PORTAS2completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Punction of V. subclavia | Procedure | — | UNRESOLVED |
| Venae sectio | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon
- interventionNames
- Procedure: Venae sectio
- type
- EXPERIMENTAL
- label
- B
- description
- Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist.
- interventionNames
- Procedure: Punction of V. subclavia
Primary outcomes (1)
- measure
- Primary success rate of the randomized intervention
- timeFrame
- Assessed on the day of surgery (day 0)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Age equal or greater than 18 years * Patients scheduled for primary elective implantation of TIAP Exclusion Criteria: * Participation in another clinical trial which could interfere with the primary endpoint of this study * Lack of compliance * Impaired mental state or language problem * Patients with known allergy to contrast agent
References
Publications (2)
- DERIVEDKnebel P, Lopez-Benitez R, Fischer L, Radeleff BA, Stampfl U, Bruckner T, Hennes R, Kieser M, Kauczor HU, Buchler MW, Seiler CM. Insertion of totally implantable venous access devices: an expertise-based, randomized, controlled trial (NCT00600444). Ann Surg. 2011 Jun;253(6):1111-7. doi: 10.1097/SLA.0b013e318214ba21. PMID 21412146
- DERIVEDKnebel P, Fischer L, Cremonese E, Lopez-Benitez R, Stampfl U, Radeleff B, Kauczor HU, Buchler MW, Seiler CM. Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients. Trials. 2008 Oct 24;9:60. doi: 10.1186/1745-6215-9-60. PMID 18950491